Post-approval phase and market access
In the post-approval phase it is important to have all the regulatory support & submissions (variations, renewals) needed. To ease your entrance on Slovenian market, we can offer you support and guidance on the fields of price and reimbursement. In MediSanus, we provide the adaptation & translation of product information (smpc, labelling & pil), moreover, we know how to address the issue of pricing & market access, which we manage with the preparation, submission, and management of various applications, renewals, notifications and with the update and upgrade of documentation. We can help with assessment of materials based on legislation and, where applicable, the industry’s Codes of Ethics. Our team can help your business also with the marketing materials review, harmonization with approved medicinal products documents, communication with authorities (new requirements/answers to deficiency/clarifications/permissions) and last but not least, with the preparation of packaging materials (mock-ups/artworks) and proofreading. All in all, MediSanus offers support with regulatory processes in the fields of marketing authorization applications, regulatory procedures, preparation and updating of SPC, patient leaflets, labelling text, due diligence review of MA’s.